A Trial Investigating the Effect of NN5401 in Subjects With Type 2 Diabetes

What Was Tested

The trial (phase 1) is built around Insulin Aspart.

This trial is conducted in Europe.

The aim of this trial is to evaluate the blood glucose-lowering effect of NN5401 (insulin degludec/insulin aspart (IDegAsp)) in subjects with type 2 diabetes.

It had six arms (groups): one (experimental), one (experimental), one (experimental), one (active comparator) and one (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 39 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months. Body mass index below or equal to 35.0 kg/m\^2.

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day); not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

Because people in this Insulin Aspart study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the participants took both Insulin Aspart and the comparison in turn, acting as their own control.

Neither the participants nor the staff measuring them knew who was on Insulin Aspart, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2010-05 with completion listed for 2010-11.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Area under the glucose infusion rate curve (only for IDegAsp).

It also tracked 2 secondary outcomes, for example Area under the insulin aspart concentration-time curve and Area under the insulin aspart concentration-time curve (only for BIAsp 30).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 39 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Aspart compound page, all human trials.